Adenoviral KeratoconjunctivitisPhase 1/2NCT04041856
Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
A Phase 1/2 study testing Povidone Ophthalmic in people with Adenoviral Keratoconjunctivitis, run by Farabi Eye Hospital.
Trial summary
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Adenoviral Keratoconjunctivitis
- What is being tested?
- Povidone Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 23 Aug 2019to 22 Nov 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suspected for viral conjunctivitis
Who cannot join
- Allergic to iodized materials
- Age under 17
Trial locations and contacts
No sites are listed yet.
About this study
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Read the detailed description
Diagnosed EKC patients will be devided into two groups,first group will undergo povidone-iodine 2% eye drop four times a day and the control group will be treated only by artificial tear drops,they will be examined 3 months later and evaluations and data collections for the final comparison will be done.
- Conditions
- Adenoviral Keratoconjunctivitis
- Being tested
- Povidone Ophthalmic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone OphthalmicDrug
Also called Povidone-iodine 2%
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
| Study group | Role | What they receive |
|---|---|---|
| EKC patients | Active comparator | Povidone-iodine 2% eye drop will be prescribed four times a day All patients will learn how to improve the hygiene level in order to reduce transmission Receives: Drug: Povidone Ophthalmic |
| Control group | No intervention | All patients will undergo observational treatments including artificial tear drop and improving hygiene level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Decreased patient's symptoms
Measured: 3 months
Povidone-iodine 2% eye drop
Decreased viral load based on PCR results
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start23 Aug 2019 (estimated)
- Primary completion22 Oct 2019 (estimated)
- Study completion22 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoviral KeratoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farabi Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammad soleimani, Farabi Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041856
- Sponsor's protocol ID
- farabieyehospital
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Povidone-iodine 2% Eye Drop Versus Artificial Tear Drop for Treatment of Adenoviral Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT04041856
- Acronym / sponsor ID
- farabieyehospital
- Conditions
- Adenoviral Keratoconjunctivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Farabi Eye HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (estimated)
- Primary completion
- 22 Oct 2019 (estimated)
- Study completion
- 22 Nov 2019 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Detailed description
Diagnosed EKC patients will be devided into two groups,first group will undergo povidone-iodine 2% eye drop four times a day and the control group will be treated only by artificial tear drops,they will be examined 3 months later and evaluations and data collections for the final comparison will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EKC patients | Active comparator | Drug: Povidone OphthalmicPovidone-iodine 2% eye drop will be prescribed four times a day All patients will learn how to improve the hygiene level in order to reduce transmission |
| Control group | No intervention | –All patients will undergo observational treatments including artificial tear drop and improving hygiene level |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suspected for viral conjunctivitis
Key exclusion criteria (2 listed)
- Allergic to iodized materials
- Age under 17
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone OphthalmicAlso: Povidone-iodine 2%Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis | Drug | EKC patients |
Primary outcome
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
Time frame: 3 months
Decreased patient's symptoms
Povidone-iodine 2% eye drop
Time frame: 3 months
Decreased viral load based on PCR results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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Adenoviral Keratoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Povidone Ophthalmic in people with Adenoviral Keratoconjunctivitis, run by Farabi Eye Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Soleimani, professor (00989121096496, Soleimani_md@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.